Method and apparatus for inflating and deflating balloon catheters

ABSTRACT

A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system may include controller that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.11/839,785, filed Oct. 18, 2007, now issued U.S. Pat. No. 8,382,747,issued Feb. 26, 2013, which is a continuation of U.S. patent applicationSer. No. 11/581,592, filed Oct. 16, 2006, now issued U.S. Pat. No.8,491,636, issued Jul. 23, 2013, which is a continuation-in-part of U.S.patent application Ser. No. 10/806,995, filed Mar. 23, 2004, now issuedU.S. Pat. No. 7,727,228, issued Jun. 1, 2010, the entirety of all ofwhich are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

FIELD OF THE INVENTION

The present invention relates to a method and system for inflating anddeflating balloon catheters and more specifically to a method and systemfor controlling the inflation and deflation of balloon catheters inorder to safely and effectively ablate a tissue region.

BACKGROUND OF THE INVENTION

The use of fluids with low operating temperatures, or cryogens, hasbegun to be explored in the medical and surgical field. Of particularinterest are the potential use of catheter based devices, which employthe flow of cryogenic working fluids therein, to selectively freeze, or“cold-treat”, targeted tissues within the body. Catheter based devicesare desirable for various medical and surgical applications in that theyare relatively non-invasive and allow for precise treatment of localizeddiscrete tissues that are otherwise inaccessible. Catheters may beeasily inserted and navigated through the blood vessels and arteries,allowing non-invasive access to areas of the body with relatively littletrauma.

Catheter-based ablation systems are well known in the art. A cryogenicdevice uses the energy transfer derived from thermodynamic changesoccurring in the flow of a cryogen therethrough to create a net transferof heat flow from the target tissue to the device, typically achieved bycooling a portion of the device to very low temperature throughconductive and convective heat transfer between the cryogen and targettissue. The quality and magnitude of heat transfer is regulated by thedevice configuration and control of the cryogen flow regime within thedevice.

A cryogenic device uses the energy transfer derived from thermodynamicchanges occurring in the flow of a refrigerant through the device. Thisenergy transfer is then utilized to create a net transfer of heat flowfrom the target tissue to the device, typically achieved by cooling aportion of the device to very low temperature through conductive andconvective heat transfer between the refrigerant and target tissue. Thequality and magnitude of heat transfer is regulated by deviceconfiguration and control of the refrigerant flow regime within thedevice.

Structurally, cooling can be achieved through injection of high pressurerefrigerant through an orifice. Upon injection from the orifice, therefrigerant undergoes two primary thermodynamic changes: (i) expandingto low pressure and temperature through positive Joule-Thomsonthrottling, and (ii) undergoing a phase change from liquid to vapor,thereby absorbing heat of vaporization. The resultant flow of lowtemperature refrigerant through the device acts to absorb heat from thetarget tissue and thereby cool the tissue to the desired temperature.

Once refrigerant is injected through an orifice, it may be expandedinside of a closed expansion chamber, which is positioned proximal tothe target tissue. Devices with an expandable membrane, such as aballoon, are employed as expansion chambers. In such a device,refrigerant is supplied through a catheter tube into an expandableballoon coupled to such catheter, wherein the refrigerant acts to both:(i) expand the balloon near the target tissue for the purpose ofpositioning the balloon, and (ii) cool the target tissue proximal to theballoon to cold-treat adjacent tissue.

One of the principal drawbacks to such a technique is that during theinflation phase coolant may seep out of the balloon and get into thebloodstream to cause significant harm. Therefore, if the balloondevelops a crack, leak, rupture, or other critical structural integrityfailure, coolant may quickly flow out of the catheter. Another situationthat may occur during the balloon deflation phase is that the balloonmay adhere to the ablated tissue causing severe damage. This may occurafter cryoablation or cryomapping. Cryomapping is a procedure thatchills conducting target tissue to create a transient electrical effect.By temporarily chilling the target tissue, it allows for precise siteconfirmation in order to prevent inadvertent ablation. Duringcryomapping, a procedure known as cryoadhesion takes place. Cryoadhesionis a procedure that ensures the catheter tip remains at the target citefor a seamless transition to cryoablation. In a cryoadhesion procedure,the tip of the catheter firmly attaches to the tissue when it freezesthereby reducing the risk of accidental slippage of the catheter tip.Therefore, during unmonitored balloon deflation, i.e. if the balloondeflates too quickly, the balloon, adhering to the tissue walls, maycause severe damage.

Accordingly, it would be desirable to provide an apparatus and method ofmonitoring and controlling the inflation and deflation phases of aballoon catheter that is adaptable and compatible with all types ofballoon ablation catheters, and with all types of ablation procedures,for example RF ablation or cryoablation.

SUMMARY OF THE INVENTION

The present invention advantageously provides a method and system forcontrollably inflating and deflating a balloon catheter. The method andsystem allows for the monitoring of the inflation and deflation phasesof a catheter system in order to allow ablation to take place, whiledetecting unwanted leaks of refrigerant into the bloodstream. Balloonleaks are identified, safety evacuation routes are provided, and acontrolled deflation mechanism is presented that prevents damage to theinterior blood vessel and tissue region, which may occur duringunmonitored deflation due to the adherence of the expandable membrane tothe interior of the vessel.

In its preferred embodiment, a method of inflating and deflating acatheter during an ablation process, the catheter having an expandablemembrane, is provided. The method comprises the steps of controllablyinflating the expandable membrane to a target pressure or volume,ablating a desired tissue region while maintaining the target pressureor volume of the expandable membrane, and controllably deflating theexpandable membrane so as not to damage desired tissue region.

In another aspect of the invention, a method for inflating and deflatinga catheter having an expandable membrane during an ablation process isprovided. The catheter is part of a catheter system including a console,the catheter, and an umbilical system coupling the console to thecatheter. The method comprises the steps of evacuating air from theexpandable membrane by creating a vacuum in the expandable membrane,controllably inflating the expandable membrane proximate a desiredtissue region, wherein the expandable membrane is inflated to a targetpressure or volume in order to provide sufficient mechanical forceagainst the desired tissue region, ablating the desired tissue regionwhile maintaining the expandable membrane at the target pressure orvolume, and controllably deflating the expandable membrane such that thedesired tissue region is not damaged.

In still another aspect of the invention, an apparatus for inflating anddeflating a catheter having an expandable membrane is provided. Theapparatus comprises a console, the console including means forcontrolling the inflation and deflation of the expandable membrane andfor determining if the expandable membrane maintains a target pressureor volume. The console also includes a pressurized inflation source. Theapparatus further includes a catheter, and an umbilical system couplingthe console to the expandable membrane and delivering pressurized mediato the expandable membrane.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1A illustrates a first embodiment of a double balloon catheter usedin conjunction with the present invention;

FIG. 1B illustrates a catheter system used in conjunction with thepresent invention;

FIG. 1C illustrates the double balloon catheter of FIG. 1A including aflow sensor located in the handle of the catheter;

FIG. 1D illustrates the double balloon catheter of FIG. 1A including apressure sensor located in the handle of the catheter;

FIGS. 2A-2E illustrate a cryoablation system incorporating variousembodiments of the apparatus and method of the present invention;

FIG. 3 is a schematic representing the mechanical components of thecontrol console of the present invention;

FIG. 4 is a schematic representing the mechanical components of theinflation circuit portion of the control console of the presentinvention;

FIG. 5 is a schematic representing the mechanical components of thedeflation circuit and main vacuum path of the control console of thepresent invention; and

FIG. 6 is a schematic representing the mechanical components of thesafety vacuum path of the control console of the present invention;

FIG. 7 is a schematic representation of the embodiment illustrated inFIG. 2A;

FIG. 8 is a schematic representation of the embodiment illustrated inFIG. 2B;

FIG. 9 is a schematic representation of the embodiment illustrated inFIG. 2C;

FIG. 10 is a schematic representation of the embodiment illustrated inFIG. 2D;

FIG. 11 is a schematic representation of the embodiment illustrated inFIG. 2E;

FIG. 12 is a schematic representation of an embodiment of a controlconsole of the present invention; and

FIG. 13 is a flow chart of an exemplary use of a control console inaccordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is an apparatus and method for controlling theinflation and deflation of balloon catheters. In its preferredembodiment, the invention requires four steps to properly control theinflation and deflation of the balloon catheter. However, the inventionallows for a variety of different implementations in order to accomplishthis task. An intermediary control station containing a shut off valveand/or a coolant source may be implemented to assist in properlymonitoring, controlling and maintaining the target balloon pressureand/or volume.

Referring now to the drawing figures in which like referencedesignations refer to like elements, a first embodiment of a doubleballoon catheter used in conjunction with the present invention is shownin FIG. 1A. The catheter 1 includes a handle 2 having a number ofproximal connector ports 3 a-3 d. Port 3 a may be a first vacuumconnector, having a first vacuum lumen therein, such as a 10 Frenchlumen. Port 3 b may be a coaxial connector having both a vacuum lumenand injection therein, the vacuum lumen being a second vacuum lumen,such as a 8 French lumen. Port 3 c may be an electrical connector. Port3 d may be a guidewire luer hub.

The handle 2 further includes a blood detection board 4 and pressurerelief valve 5. The distal end portion of the catheter 1 includes twoballoons: an inner balloon 6 a and an outer balloon 6 b surroundinginner balloon 6 a. A soft distal tip 7 is located just distal to the twoballoons 6 a and 6 b. When refrigerant is injected into the balloonsalong lines R as shown, vacuum applied through the ports 3 a and 3 bwill serve to draw any fluid within balloons 6 a and 6 b along arrows Vout of the balloons and the catheter. Radiopaque marker bands M arelocated proximate the exit point of the refrigerant injected intoballoon 6 a to aid in the positioning and tracking of the device.

Catheter 1 includes an elongate shaft having a guidewire 8 and an innershaft 9 a and outer shaft 9 b. Exemplary embodiments of the inner shaft9 a include an 8 French shaft, while exemplary embodiments of the outershaft 9 b include a 10 French shaft.

A typical catheter system 10 is shown in FIG. 1B. The system includes aconsole 20 coupled to one end of an umbilical system 12. The opposingend of umbilical system 12 is coupled to an energy treatment device 22.Energy treatment device 22 may be a medical probe, a catheter, aballoon-catheter, as well as other devices commonly known in the artthat are smooth enough to pass easily through blood vessels and heartvalves. As shown in FIG. 1A, the energy treatment device 22 includes aballoon structure 23 that can be a single wall or a double wallconfiguration, wherein the double wall configuration places the spacebetween balloon walls in communication with a vacuum source.

Umbilical system 12 is comprised of three separate umbilicals: a coaxialcable umbilical 14, an electrical umbilical 16 and a vacuum umbilical18. An outer vacuum umbilical is used in the case of a double balloonsystem; it is not necessary for a single balloon system having only onevacuum lumen. If the user wishes to perform an RF ablation procedure,radiofrequency energy can be provided to electrodes on device 22 viaelectrical umbilical 16 to perform an RF ablation technique as is commonin the art. Electrical umbilical 16 can include an ECG box 82 tofacilitate a connection from electrodes on catheter 22 (not shown) to anECG monitor. Coaxial umbilical 14 includes both a cooling injectionumbilical and a vacuum umbilical that provide respective inlet andreturn paths for a refrigerant or coolant used to cool a tissue-treatingend of device 22. The vacuum umbilical 18 is used as safety conduit toallow excess coolant or gas to escape from device 22 if the pressurewithin the balloon on device 22 exceeds a predefined limit. The vacuumumbilical 18 can also be used to capture air through a leak of the outervacuum system where it is outside the patient and as a lumen to ingressblood when in the patient.

Referring once again to FIG. 1B, catheter system 10 may include one ormore sensors #, which are used to monitor the amount of fluid or gasrefrigerant injected through the umbilical system and into the balloons.It is contemplated that the sensors may be located in one of severallocations throughout catheter system 10. For example, sensor 11 may belocated in console 20, ECG Box 82, and/or handle 2.

Two different types of sensors are contemplated for use with the presentinvention in order to monitor how much coolant is flowing into theballoons. A flow sensor 13 shown in FIG. 1C, measures the rate or speedof fluid or gas at a certain location. An exemplary embodiment of flowsensor 13 is the Microbridge Mass Air Flow Sensor by Honeywell®.

Alternately, one or more sensors 11 may be a pressure sensor 15 as shownin FIG. 1D. Pressure sensor 15 in FIG. 1D is a differential pressuresensor that can determine the amount of pressure in the balloons bydetermining the difference in pressure between points p₁ and p₂ and thevelocity through the restriction point d. An exemplary embodiment ofpressure sensor 15 is the 26PC SMT Pressure Sensor by Honeywell®.

FIGS. 2A-2E illustrate different embodiments of the catheter system 10of the present invention. In general, the inflation/deflation systemdescribed herein can be used with both single and double balloonsystems. For a single balloon system, the refrigerant is sprayed intothe balloon and creates a circumferential region of cooling around theballoon's perimeter. The refrigerant expands and the vapor is drawn backinto the console via the return vacuum lumen. With respect to a doubleballoon system, a second balloon and second vacuum lumen envelop thesingle balloon system and are always maintained under vacuum for safetyreasons. The vacuum of the outer balloon will capture refrigerantescaping through any breach of the inner balloon system. A flow switchmounted on the outer vacuum system is used to monitor any flow activity.Under normal operation, no fluid should pass through the outer vacuumsystem. Any discussion of a “flow switch” herein implies a doubleballoon system. Otherwise, all inflation/deflation methods also apply toa single balloon catheter.

Each embodiment includes a console 20 or console 21, an umbilical systemcomprised of varying combinations of separate umbilicals, and anablation device 22. Each of the embodiments shown in FIGS. 2A-2E isrepresented by more detailed corresponding schematics in FIGS. 7-11,respectively, and are discussed in greater detail below.

FIG. 2A represents a typical catheter ablation system 10. Console 20 iscoupled to a catheter 22 via an umbilical system 12, comprised ofcoaxial umbilical 14, which transfers coolant from console 20 tocatheter 22 and provides a return conduit for the coolant, electricalumbilical 16, which transfers RF energy from console 20 to catheter 22during an RF ablation procedure or electrical signals during acryoablation procedure, and safety vacuum umbilical 18, to allow forquick evacuation of coolant if needed.

Coolant is provided by a coolant source within console 20. Coolant,typically N₂O, passes through the internal piping of console 20 beforebeing transferred to catheter 22 via the coaxial umbilical 14. At thedistal end of the umbilical, inside catheter 22, the coolant is releasedinside the catheter tip cavity, which is under vacuum. Both the phasechange from liquid to gas and the sudden expansion of the coolant areendothermic reactions, causing a temperature differential which resultsin the catheter tip or balloon freezing. The coolant vapor is thenreturned through the vacuum path via umbilical 14 and into console 20,where it is evacuated through a scavenging line.

FIG. 2B represents another catheter ablation system. However, in thisembodiment, an intermediary station 74 is inserted into the cathetersystem. As explained in greater detail below, station 74 containsdetection valves to detect a drop in balloon pressure which mightindicate a leak, and shut off valves to terminate balloon inflation ifnecessary. Station 74 is coupled to console 21 and catheter 22 viaelectrical umbilical 16 and coaxial umbilical 14. Vacuum umbilical 18provides an emergency evacuation path for coolant from the catheter.

FIG. 2C represents the catheter ablation system of FIG. 2A including asecondary coolant source 78 used to re-inflate the expandable membrane,or balloon 23 of catheter 22 via syringe 76.

FIG. 2D illustrates two possible configurations for the ablation system.In a first configuration, a secondary coolant source includes a smalltank or canister 80 located within an intermediary station 74. In asecond configuration, the secondary coolant source includes a small tankor canister 60 located inside the console 21. In both configurations,the secondary coolant source is independent from the source of coolingprovided by other components within the console 21 (the primary coolantsource), and it does not require the same type of refrigerant that isprovided by the primary coolant source.

FIG. 2E illustrates a configuration where the secondary cooling sourceand the primary cooling source are unified and thus share the samesource of refrigerant.

FIG. 3 refers to a schematic representing the console 20 portrayed inFIGS. 2A and 2C. The schematic shown is designed specially for ballooncatheters and contains a series of two and three-way solenoid valves andregulators that assist in monitoring the pressure of the ballooncatheter 23, which may drop quickly if a leak of fluid occurs. Device 22(shown in FIGS. 2A-2E) is a catheter with an expandable membrane 23 atits distal end. Console 20 is represented by the schematic in FIG. 3that shows the layout of the internal mechanical components of console20.

In an exemplary embodiment, the system is operated in four phases. Thefirst phase is the evacuation/flushing phase. When the catheter 22 isinserted inside the patient it is first necessary to evacuate airmolecules from within the catheter, air contained inside the umbilicalconnecting the catheter 22 to the console 20, as well as from thecatheter shaft itself. Although it is not theoretically possible toevacuate 100% of the air molecules, by minimizing the amount of airwithin the umbilical and catheter shaft, the catheter is prepared forinflation and then ablation, while minimizing the dangers associatedwith fluid egress.

During the evacuation/flushing phase, a 3-way solenoid valve 24 is opentoward vacuum pump 26, which ensures that there is a vacuum in catheter22. The 3-way solenoid valve 24 can be replaced by a PID-drivenproportional valve. In either configuration, the 2-way solenoid 28 thatsupports high pressure is closed to prevent any high-pressure gas fromreservoir 30 from entering the inner vacuum system/balloon catheterduring the refilling process. Reservoir 30 could be a tube or reservoircontaining enough fluid volume to fill the umbilical tubes and catheter22 to a predefined pressure. If the pressure within reservoir 30 exceedsa predetermined pressure setpoint, a check valve 32 will open toevacuate the exceeded amount of coolant such as, for example, nitrousoxide (N₂O) in the system in order to keep a fixed amount of nitrousoxide in reservoir 30. During this phase, reservoir 30 is filled withN₂O received from N₂O source 60. The N₂O is received from a highpressure line after leaves tank 60 and passes through a series ofregulators, namely, a first regulator 34, a second regulator 36 and theninto either a third regulator 38 or a proportional valve, that areadjusted to the predetermined pressure. The reservoir pressure can becontrolled through a pressure regulator 38 or through a proportionalvalve that would refill the tank with different pressure setpoints fordifferent balloon sizes or different inflation pressures. The pressuresetpoint can be programmed into a circuit, chip or other memory devicethat can be located in the handle.

Refilling valve 40 opens for a period of time and fills reservoir 30.During this phase, the 2-way solenoid valve 28 remains closed. Also,during this phase, the system is under vacuum and provides verificationfor any leaks that occur.

Thus, when the catheter is outside the patient, any breach of the inneror outer vacuum systems will be detected by a high baseline flow throughthe console flow meter. In addition, a flow switch located in theconsole or in the catheter handle and mounted on the outer vacuum systemwill also detect a leak of air through a breach of the outer balloon orvacuum lumen. The flow switch is capable of detecting volumes of gas aslittle as 1 cc of vapor, and flow rates as little as 20 sccm. When thecatheter is inserted into the patient, blood ingress through either theinner or outer vacuum lumens or both will be detected by the leak andblood detection systems. In the case of a constant pressure inflationwith circulating flow, the balloon pressure can also be controlled witha PID-driven proportional valve located on the return vacuum lumen or athree-way solenoid valve in series with a pressure switch or pressuretransducer.

Referring to FIG. 4, the inflation phase of the invention will now bediscussed. Prior to positioning catheter 22 on the ablation site, thephysician must first inflate the expandable membrane 23 inside the heartchamber and then position the balloon 23 proximate the ablation site.During this phase, the system is under vacuum and provides verificationfor leaks between balloon 23 and the blood. In one embodiment, balloon23 is inflated by injecting fluid or gas through the umbilical under afixed flow pressure. This insures a defined and constant pressure insidethe balloon in order to provide a mechanical force for inflation. Analternate way to inflate balloon 23 is to use a fixed volume ofinflation. This volume would be minimized in order to meet theconstraints related to gas egress within the blood stream (maximum of 20cc within 10 minutes) and meet the requirement for pressure needed toinflate the balloon under the harshest room conditions.

FIG. 3 illustrates the inflation portion of the console mechanics ofFIG. 2. During the inflation phase, valve 24 is open toward reservoir 30and valve 28 opens, while refilling valve 40 remains closed. A fixedamount of N₂O is injected to inflate balloon 23 in order to providesufficient mechanical force for inflation. If a leak occurs in theballoon, the released volume of N₂O would be no more than 20 cc. Thesolenoid valve 44 remains open during this phase in order to ensure avacuum in the safety line. If a leak occurs in the inner balloon of thecatheter, the flow switch 42 (FIG. 3), detects leaks as small as 1 cc ofvapor. Flow switch 42 is active during all phases to prevent any leak ofthe inner balloon system in catheter 22. The leak and blood detectionsystems are still active and monitoring any blood ingress through theouter vacuum lumen. After air has been flushed from catheter 22 and theumbilicals connecting catheter 22 to console 20, and balloon 23 has beeninflated, ablation may now take place.

A transition mode follows inflation but precedes ablation. In the caseof cryogenic ablation systems, a transition method is needed totransition from closed pressurized volume to an open circuit, whichallows the flow of refrigerant to enter and exit the catheter tip whileat the same time controlling the balloon pressure in order to keep theballoon inflated and in place. During the transition, a pressure switch,which is adjusted to a pressure higher than atmospheric pressure butpreferably lower than 20 psia, monitors the pressure inside the ballooncatheter 22. The solenoid valve 24 remains closed until the pressure inthe catheter is higher than the preset switch value after which thesolenoid valve opens to allow evacuation of excess refrigerant. When thepressure falls below the reset switch value, the solenoid valve 24closes to keep the balloon inflated and above atmospheric pressure.During the transition, ablation is already initiated but the pressureswitch controls the balloon pressure until refrigerant flow alonemaintains the balloon open and above atmospheric pressure. Thetransition phase is considered complete when certain conditions aremet: 1) when the pressure switch commands the solenoid valve 24 to opento vacuum and the balloon pressure remains above the present switchvalue; 2) the duration of the transition phase exceeds a predeterminedtime; and 3) the injection pressure reaches a predetermined value thatis adequate to generate enough flow to maintain the balloon open. Checkvalve 56 is used to prevent any abnormal rise in the pressure in thecatheter tip. Another check valve 58, shown also in FIG. 6, prevents anyexcessive pressure in the safety vacuum line and in the event thesolenoid valve 44 is blocked.

During the ablation phase, refrigerant is injected through the umbilicalsystem into the ablation device 22. When injection of refrigerant isdesired, N₂O gas is released from source 60 and provides high pressureliquid through a check valve 62 and a series of pressure regulators 34and 36. Regulators 34 and 36 are primary and secondary pressureregulators respectively, which serve to bring the gas pressure down tobetween 810 and approximately 840 psig. The liquid nitrous oxide goesthrough a proportional valve 64 driven by a Proportional IntegralDerivative (PID) controller 66 so that the refrigerant pressure can bevaried from 0 psig to approximately 760 psig, and through an injectionsolenoid valve 68 which remains open. The N₂O then passes through asub-cooler 70 with various refrigeration components such as acompressor, a condenser, a capillary tube and a heat exchanger, whichinsures its liquid state through the umbilical and into the smalldiameter catheter injection tubing. During injection, solenoid ventvalve 46 is closed. To detect a failure of this valve, the pressureswitch 72 will close when detecting a pressure higher than 15 psig,creating a failure signal.

During the injection phase, proportional valve 64 is used to vary thepressure inside the injection line. This in turn will vary the flow rateof refrigerant to the catheter tip. An increase in the flow rate (lessrestriction by the regulator) lowers the temperature of the cathetertip. Conversely, decreasing the flow rate allows the catheter tip to bewarmed by its surroundings.

FIG. 5 illustrates the deflation and main path circuitry of the presentinvention. At the end of the ablation phase, the system provides amethod to insure a controlled/slow deflation in order to preventdamaging the ablated tissue during balloon deflation. This can be ahazard due to cryoadhesion, which may occur when the catheter attachesto the tissue during freezing. Referring to both FIGS. 3 and 5, duringdeflation, the solenoid valve 24 (FIG. 3) remains closed until thetemperature in the balloon is higher than a predetermined temperature(usually above freezing to ensure that surrounding tissue has thawed).When the temperature increases to greater than the predeterminedtemperature, the solenoid valve 24 opens to vacuum and collapses theballoon. On both vacuum paths, liquid sensors and insulated liquidseparators 48 and 50 (FIG. 3) are installed to prevent any liquid fromentering the vacuum pump 26. If this occurs, injection and/or inflationwill be stopped and both valves 52 (FIG. 3) and 44 (FIG. 3) will switchto atmosphere.

FIG. 6 illustrates the safety vacuum portion of the console circuitry ofFIG. 3. If a leak occurs in the catheter during inflation or ablation,flow switch 42 can detect such a leak in amounts as small as 1 cc ofvapor. Upon detection of the leak, inflation of the balloon catheter isstopped. Prior to inflation, the flow switch can detect leaks of theouter balloon or guide wire lumen when the catheter is in the air. Incase of pressurization of the safety vacuum line ⅓ psi aboveatmospheric, a pressure relief valve 58 located distal to the flowswitch will vent excess pressure.

Referring now to FIG. 7, one embodiment of the present invention isshown. The schematic in FIG. 7 illustrates the mechanical connection ofthe console 20, umbilical system 12 and catheter 22. The representationin FIG. 7 corresponds to the embodiment shown in FIG. 2A. The internalcomponents of console 20 are similar and correspond to those shown ingreater detail in FIG. 3 explained above. In this embodiment, theballoon 23 is inflated by receiving gas or fluid from source 60 viacoaxial umbilical 14. PID controller 66 controls the flow of pressurizedfluid/gas from console 20 through umbilical system 12 to balloon 23.

FIG. 8 shows an alternate embodiment of the invention in which anintermediary station 74 containing all components and circuits tooperate the balloon catheter is coupled to console 10, between theconsole and balloon catheter 23. Station 74 includes a series ofshut-off valves and detection switches. Detection circuitry withinstation 74 can detect if the volume of gas within balloon catheter 23has exceeded a certain predetermined amount (i.e. 20 cc within thecatheter and the umbilical system), and shut-off valves within station74 are activated, preventing any further inflation. Station 74advantageously provides a quicker and more effective way of detectingleakage of gas or liquid into the blood stream. If the pressure withinballoon catheter 23 drops, this could be an indication that fluid withinthe balloon has escaped. By inserting station 74 within system 10, aquicker and more efficient way of detecting leaks and preventingunwanted balloon inflation is provided.

FIG. 9 shows yet another embodiment of the invention. Here, ballooninflation can be performed by a syringe 76 coupled to a saline watersource 78 or any other fluid media including gasses or liquids. Thisembodiment becomes practical when manual balloon inflation is required.

In FIG. 10, intermediary station 74 includes a second inflation source80. As in the embodiment depicted in FIG. 8, leak detection circuitryand shut-off valves located in station 74 provide an efficient way ofdetecting leaks and quickly prohibiting the further inflation of ballooncatheter 23. Should further inflation be required, a separatepressurized N₂O source 80 is provided in station 74, which is at acloser and more convenient location, i.e. nearer the catheter and not ina remote location such as console 20.

In FIG. 10, the refilling source 80 is located in the intermediate box74 and inflation occurs through the outer vacuum umbilical. In FIG. 11,the refilling source is the coolant tank 60 located in the cryoablationconsole and inflation occurs through the inner vacuum umbilical.

Now referring to FIG. 12, a schematic representation of a console 100for use with a medical device is shown. As previously discussed, theconsole 100 includes various mechanical and/or electrical components toassist in the operation, control, and/or monitoring of a medical device,such as the catheter 1 described above. Primarily, the console 100 maybe coupled to the catheter 1 through an umbilical connector 102, whichplaces a supply lumen 104 and an exhaust lumen 106 of the console 100 influid communication with the catheter. In general, the console 100 mayfurther include a first coolant reservoir 108, a second coolantreservoir 110, and a vacuum source 112. As used herein, the term‘reservoir’ is intended to include any container or chamber able tocontain a fluid. As such, either of the first or second reservoirs mayinclude a tank, container, or even a length of tubing or the likedefining an interior space between two or more valves. The secondcoolant reservoir 110 may have a volumetric capacity smaller than thevolumetric capacity of the first coolant reservoir 108, and the secondcoolant reservoir 110 may have a volumetric capacity of approximatelytwenty cubic centimeters, which has been shown to reduce the likelihoodof cardiac abnormalities and/or failure due to coolant egress into thevascular system. The vacuum source 112 may include any structure and/orapparatus able to provide a negative pressure gradient for providingfluid flow, including pumps, plunger devices, or the like.

One or more valves may be disposed about the console 100 in fluidcommunication with the supply lumen 104 and/or the exhaust lumen 106 formanipulating and/or providing fluid flow along a desired path. Forexample, the console 100 may include a pair of valves, 114 and 116, influid communication with the first coolant reservoir 108 such that thefirst coolant reservoir 108 may be selectively switched from being influid communication with the second coolant reservoir 110 to being influid communication with the supply lumen 104. Moreover, a valve 118 maybe disposed on the exhaust lumen 106 such that the exhaust lumen 106 maybe selectively switched from being in fluid communication with thesecond coolant reservoir 110 to being in fluid communication with thevacuum source 112. In addition, the console 100 may include one or morecheck valves and/or pressure relief valves CV configured to open toatmosphere or to a recovery tank should a pressure level and/or flowrate within a portion of the console 100 exceed a desired orpredetermined level.

The console 100 may include a valve 119 in fluid communication with boththe supply lumen 104 and the exhaust lumen 106. In particular, the valve119 may be in fluid communication with the supply lumen 104 at aposition upstream of the umbilical connector 102, while being in fluidcommunication with the exhaust lumen 106 downstream from the umbilicalconnector 102. The valve 119 may further be placed in fluidcommunication with the surrounding atmosphere to vent excess coolantand/or to relieve or equalize pressure in both the exhaust and supplylumens. During operation, the console 100 may detect a failure of themedical device, such as an indication of the presence of blood or bodilyfluid being entrained into the coolant system. Upon such detection,coolant flow may be terminated. However, despite the termination ofcoolant flow, due to the built-up pressure levels in the supply andexhaust lumens, bodily fluid may continue to be siphoned into themedical device and thus into portions of the console 100. To reduce thelikelihood that siphoning occurs, the valve 119 may be actuated to placeboth the supply lumen 104 and the exhaust lumen 106 into fluidcommunication with the atmosphere. By doing so, the pressure in eitherlumen will be substantially equalized and thus will prevent the furtheringress of bodily fluids into the medical device and thus the console.Of course, the equalization and/or subjection of both the supply andexhaust lumens may be achieved by using one or more valves in variousconfiguration.

The console 100 may also include a subcooler 120 disposed about aportion of the supply lumen 104 for achieving a desired temperatureand/or coolant phase of fluid flowing therethrough. The subcooler 120may include a compressor, condenser and the like placed in thermalcommunication with the supply lumen 104 as previously discussed.

One or more sensors may be disposed about the supply and exhaust lumensof the console 100 for detecting temperature, pressure, and/or flowrates through a particular portion of the console 100 plumbing. Forexample, a first pressure sensor 122 may be disposed about the exhaustlumen 106 proximate to the umbilical connector 102. In addition, asecond pressure sensor 124 may be disposed about the supply lumen 104.Of course, additional sensors SS may be included throughout the console100 for monitoring and/or controlling particular portions of the consoleand properties thereof.

In addition to the one or more sensors, one or more controllers may becoupled to the sensors, and in turn, coupled to one or more of thevalves situated throughout the console 100 such that the valves may becontrollably manipulated in response to information obtained by thesensors. For example, a first controller 126 may be coupled to the firstpressure sensor 122, wherein the first controller 126 is further coupledto a valve 128 disposed on a portion of the exhaust line, and where thevalve 128 may also be in fluid communication with the vacuum source 112.In addition, a second controller 130 may be coupled to the secondpressure sensor 124, where the second controller 130 is further coupledto a valve 132 disposed about the supply lumen 104. Accordingly, fluidflow through portions of the exhaust and/or supply lumens may becontrollably manipulated in direct response to the information obtainedby sensors contained therein.

In an exemplary use, the console 100 may be used for operating a medicaldevice, such as the catheter 1, through four different phases. A flowchart of such an exemplary use is provided in FIG. 13. As previouslydiscussed, the first phase is the evacuation or flushing phase, in whicha medical device is substantially evacuated of any fluid. During thisphase, a valve 134 disposed on the exhaust lumen 106 between theumbilical connector 102 and the vacuum source 112 is opened, therebysubjecting the medical device to a reduced pressure gradient andproviding for the evacuation of any fluid therein. The valve 116 may beclosed to prevent fluid from being drawn from the first coolantreservoir 108, and further, the valve 118 may be in a configuration suchthat the second coolant reservoir is also isolated from the pressuredifferential created by the vacuum source 112. Once evacuated to asuitable degree, the catheter may be positioned in and/or around aparticular region of a patient to be treated.

During an inflation stage of use, coolant is transferred from the firstcoolant reservoir 108 to the second coolant reservoir 110, andsubsequently to an attached medical device. The coolant flowing from thefirst coolant reservoir 108 to the second coolant reservoir 110 mayconsist of coolant vapor in a gaseous state obtained from the firstcoolant reservoir 108. The coolant transfer may be achieved by havingthe valve 116 in a closed position, while opening valve 114, therebyplacing the first coolant reservoir 108 in fluid communication with thesecond coolant reservoir 110 rather than the supply line of the console100. Once the second coolant reservoir 110 has been adequately filledwith coolant to a desired level, the coolant from the second coolantreservoir 110 may then be transferred towards the exhaust lumen 106 ofthe console 100, and subsequently to the exhaust line of the coupledmedical device, such as catheter 1. During the transfer from the firstreservoir 108 to the second coolant reservoir 110, the valve 118 may beconfigured to prevent coolant from being transferred into the exhaustlumen until desired.

In the inflation phase, both the valve 116 and the valve 134 are closed,while valve 118 provides fluid communication between the second coolantreservoir 110 and the exhaust lumen 106 at the umbilical connector 102,and thus providing fluid communication with the exhaust lumen 106 of thecatheter. Since both valves 116 and 134 are closed, the catheter isconfigured into a closed system with the coolant from the second coolantreservoir 110. Accordingly, the volume of coolant provided to thecatheter from the second coolant reservoir 110 may be adjusted toprovide an expected or predetermined pressure level within a portion ofthe medical device. In particular, as in the case with the catheter, thefixed volume being provided by the second coolant reservoir 110 may beselected to produce a target inflation pressure in the balloon of thecatheter. This target level may be used to insure that the balloon isindeed inflated to a desired degree. While a particular desired ortarget pressure within a portion of the medical device may vary byapplication or specification of a particular medical device, the targetpressure may be in a range of approximately atmospheric pressure toapproximately 30 psia. Moreover, as the pressure within the exhaustlumen 106, and thus the balloon of the catheter, can be monitored withthe pressure sensor 122, any variation in the measured pressure from theexpected pressure level may indicate a leak or failure of the medicaldevice. Moreover, as previously discussed, the second coolant reservoir110 may have a smaller capacity than the first coolant reservoir 108,and as such, should the medical device experience a failure or leak, theamount of coolant escaping into the patient is thereby limited in amountto the capacity of the second coolant reservoir 110 rather than thefirst coolant reservoir 108. This limited capacity may prevent and/orreduce the likelihood of complications arising from excess coolantentering the bloodstream, as previously suggested. In addition toverifying the structural integrity of the medical device and providing asafeguard, the inflation stage allows a physician to securely position amedical device prior to actually effecting treatment of the targettissue.

Following the inflation phase is a transition phase of use for theconsole 100 and/or medical device. The transition phase includesproviding increased coolant flow within the medical device whileensuring that the balloon does not deflate, which could cause thephysician to lose the desired positioning of the medical device. Inparticular, the transition phase may include opening valve 116, andfurther switching valve 118 to place the exhaust lumen 106 in fluidcommunication with the controlled valve 128. As such, the balloon of thecatheter 1 is placed in fluid communication with the first coolantreservoir 108 through the supply lumen 104, and is further placed influid communication with the vacuum source 112 through the exhaust lumen106.

Subsequently, coolant, perhaps in a liquid state, may be transferredfrom the first coolant reservoir 108 through the supply lumen 104 to theballoon such that the coolant flow is regulated and/or controlled by theoperation of the valve 132, which, as previously described, may becontrolled by the second controller 130 in response to the secondpressure sensor 124. In addition, the coolant flow through the balloonand the exhaust line may also be affected by the operation of valve 128,which may be manipulated via a feedback loop with the first controller126 and the first pressure sensor 122. The operation of the twocontrollers and the adjustable valves 132 and 128 may occursubstantially simultaneously and/or alternatively in order to maintainthe inflation of the balloon of the catheter at a desired and/or targetpressure as coolant flow through the medical device is increased toachieve a desired or target flow rate. For example, the 132 valve may bemanipulated to provide stepped increases in flow rate and/or flowpressure from the first coolant reservoir 108 to the supply lumen 104,where the 128 valve is adjusted in response to the setting of the valve132 to provide adequate fluid communication with the vacuum source 112to achieve the desired target coolant flow rate through the medicaldevice.

While a suitable coolant flow rate may vary depending on the particulartreatment being sought and/or depending on the dimensions andspecifications of a particular medical device, the target coolant flowrate may be in the range of approximately 2500 sccm to 5000 sccm. Thetransition phase is ended when the target coolant flow rate is achievedand/or wherein further manipulation of the adjustable valves 132 and 128is no longer desired. The transition phase may further be completed uponsubjecting the supply lumen 104 and exhaust lumen 106 to an unimpeded,maximum flow rate providable by the first coolant reservoir 108 and thevacuum source 112.

Following the transition phase and once a desired coolant flow rate hasbeen achieved, the console 100 may be operated in a treatment phase. Thetreatment phase generally includes providing coolant flow to the medicaldevice at the target coolant flow rate such that the desired thermaltreatment may be provided to the target tissue. For example, theparticular treatment may include the ablation of tissue, which may beachieved by the temperature resulting in a portion of the medical devicedue to the coolant flow therein.

Upon completion of the treatment phase, coolant flow to the medicaldevice may be reduced and or eliminated, but the balloon of the medicaldevice may remain in an inflated state until a predetermined targettemperature has been reached. As previously discussed, in order to avoidor reduce the likelihood of unwanted tissue damage due to cryoadhesionof the device to the tissue, it may be desired to ensure that anyadhesion is eliminated prior to removal and/or repositioning of themedical device. In a particular example, coolant flow from the firstcoolant reservoir 108 may be reduced and/or terminated, such as byclosing valve 116. In turn, valve 134 may be closed such that theadjustable valve 128 may regulate coolant evacuation from the exhaustline and thus the medical device. The valve 128 may correspondinglyallow for the evacuation of coolant at a controllable rate such theballoon of the medical device remains in an inflated state until apredetermined target temperature is achieved at the balloon. Whileapplications may vary, the target temperature may be a temperature aboveapproximately −10° C. to 20° C. to ensure that any ice formation isthawed, and the temperature in the balloon may be monitored by one ormore temperature sensors affixed to the medical device in communicationwith the console 100. The temperature may be monitored by a temperaturesensor within the balloon, but may further be monitored by a sensorpositioned on an outer surface of the balloon or by a sensor in thermalcommunication with a supply or exhaust lumen of the medical device. Uponachieving the predetermined target temperature, the valve 134 may thenbe opened, subjecting the medical device to a substantially unimpededpressure gradient provided by the vacuum source 112, and thus allowingthe balloon to collapse by the evacuation of coolant therein.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention, which is limited only by the following claims.

What is claimed is:
 1. A method of operating a medical device having anexpandable element in fluid communication with a supply lumen and anexhaust lumen, the method comprising the steps of: providing a firstcoolant reservoir, a second coolant reservoir and a vacuum source,wherein the first coolant reservoir, the second coolant reservoir, andthe vacuum source are in fluid communication with the expandable elementof the medical device; transferring coolant from the first coolantreservoir to the second coolant reservoir; transferring the coolant fromthe second coolant reservoir to the expandable element through theexhaust lumen, wherein the expandable element is inflated to a targetpressure; transferring the coolant from the first coolant reservoir tothe expandable element through the supply lumen; and evacuating thecoolant from the expandable element with the vacuum source, wherein thesteps of transferring the coolant from the first coolant reservoir tothe expandable element and evacuating the coolant from the expandableelement are regulated to achieve a target coolant flow rate whilemaintaining a pressure in the expandable element at a levelsubstantially equal to or greater than the target pressure.
 2. Themethod according to claim 1, further comprising the steps of:terminating the transferring of the coolant from the first coolantreservoir to the expandable element; wherein the pressure is maintainedin the expandable element at the level substantially equal to or greaterthan the target pressure until the expandable element achieves apredetermined temperature.
 3. The method according to claim 1, whereinthe step of transferring the coolant from the first coolant reservoir tothe expandable element includes a stepped increase of coolant transfer.4. The method according to claim 1, wherein the coolant transferred fromthe second coolant reservoir to the expandable element is in a gaseousstate.
 5. The method according to claim 4, wherein the coolanttransferred from the first coolant reservoir to the expandable elementis in a liquid state.
 6. The method according to claim 1, wherein thetarget coolant flow rate is greater than approximately 2500 sccm.
 7. Themethod according to claim 1, wherein the target pressure is greater thanapproximately atmospheric pressure.
 8. The method according to claim 1,wherein the second coolant reservoir defines a volumetric capacitysubstantially less than a volumetric capacity of the first coolantreservoir.
 9. The method according to claim 8, wherein the volumetriccapacity of the second coolant reservoir is less than approximatelytwenty cubic centimeters.
 10. The method according to claim 1, whereinthe second coolant reservoir is defined by a length of tubing defining alumen therein.
 11. The method according to claim 1, further comprising astep of placing both the supply and the exhaust lumen in fluidcommunication with the atmosphere upon an indication of medical devicemalfunction.